Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as retaspimycin hydrochloride, Docetaxel
IPI-504 · 7 trials · 10 indications
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
| Arm | Type | Description |
|---|---|---|
| ARM 1: IPI 504 + Docetaxel | ACTIVE_COMPARATOR | Drug: IPI-504 plus Docetaxel |
| Placebo + Docetaxel | PLACEBO_COMPARATOR | Placebo plus Docetaxel |
| IPI-504: Group A | EXPERIMENTAL | No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed \>2 years prior to study) |
| IPI-504: Group B | EXPERIMENTAL | * Must have evidence of radiographic metastatic disease * Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy * No more than three prior chemotherapies regimens for HRPC |
| Retaspimycin HCl (IPI-504) and Everolimus | EXPERIMENTAL | Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs. |
| 1 | EXPERIMENTAL | Schedule A: Doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration. |
| 2 | EXPERIMENTAL | Schedule B: Doses occur on Days 1, 4, 8, 11, 15, and 18 (twice weekly for 3 weeks continuously). |
| Name | Type | Description |
|---|---|---|
| IPI 504 plus Docetaxel | DRUG | 450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) |
| Placebo plus Docetaxel | DRUG | 450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) |
| IPI-504 | DRUG | IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle |
| Everolimus | DRUG | - |
| IPI-504, docetaxel | DRUG | 1. IPI-504 administered IV at a dose of 300mg/m2 2. Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration |
Inclusion Criteria: * Patients must be ≥18 years of age * Voluntarily signed an informed consent * Confirmed NSCLC and Stage IIIB or IV disease. * At least a ≥15 pack year smoking history and must have been an active smoker within 20 years of diagnosis. * Must have archival NSCLC tissue available t...
Top 20 of 74 competitors